Thermal performance optimization in a thermal therapy device

ABSTRACT

A rapid contrast therapy system can provide cold, heat/hot/warm (hereafter referred to as “hot”), and/or rapid contrast therapy, which involves rapidly alternating between cold therapy and hot therapy. The system can circulate cold or hot fluid, such as water, through a hose, into a therapy wrap, and then back to the fluid reservoirs of the system. The system can utilize a vapor compression system or other chiller technology to cool the cold water reservoir, and immersion heaters can be used to heat the hot water reservoir.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/455,658, filed Jun. 27, 2019, which claims the benefit of andpriority to U.S. Provisional Pat. App. No. 62/690,875, filed Jun. 27,2018, both of which are incorporated herein by reference in theirentireties.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present disclosure relates generally to thermal therapy of ananimate body, and more particularly to rapid contrast therapy whichalternates rapidly between cold therapy and hot therapy.

BACKGROUND

It is now common to apply cold and compression to a traumatized area ofa human body to facilitate healing and prevent unwanted consequences ofthe trauma. In fact, the acronym RICE (Rest, Ice, Compression andElevation) is now used by many.

Typically, thermally-controlled therapy involves cold packing with icebags or the like to provide deep core cooling of a body part. Therapyoften involves conventional therapy wraps with a fluid bladder forcirculating a cooled heat exchange medium. Elastic wraps are oftenapplied over the therapy wrap to provide compression.

More recently therapy wraps including a pair of compliant bladders tocontain fluids have been disclosed. The therapy wrap typically has acompliant bladder for containing a circulating heat exchange liquidalone or in combination with a compressive bladder which overlays thecompliant bladder for pressing the bladder against the body part to besubjected to heat exchange. In general, the body heat exchangingcomponent(s) of such an apparatus include a pair of layers defining aflexible fluid bladder through which a liquid is circulated. Thestructure embodying both the liquid bladder and compressive bladdercomponent is often referred to as a “wrap.” The liquid fed to the wrapis maintained at a desired temperature by passing the liquid through aheat exchanging medium such as an ice bath or a refrigeration unit. Onesuch system is disclosed, for example, in U.S. Pat. No. 6,178,562 toElkins, the disclosure of which is herein incorporated for all purposesby reference.

In some cases, heat treatment in conjunction with cryotherapy canprovide benefits to the patient when provided in a rapidly alternatingmanner called rapid contrast therapy. Historically, this was done byalternating immersion in hot and cold water baths. However, use of hotand cold water baths is cumbersome and inconvenient to apply. Therefore,it would be desirable to provide a system and method for convenientlydelivering rapid contrast therapy, cold therapy alone, heat therapyalone, and/or compression therapy.

SUMMARY

The present disclosure relates generally to thermal therapy of ananimate body, and more particularly to rapid contrast therapy whichalternates rapidly between cold therapy and hot therapy.

In some embodiments, a system for providing rapid contrast therapy isprovided. The system includes a cold reservoir configured to hold a coldliquid; a hot reservoir configured to hold a hot liquid; a cold fillport in fluid communication with the cold reservoir; a hot fill port influid communication with the hot reservoir, wherein both the cold fillport and the hot fill port are housed in a receptacle that is configuredto accommodate fluid overflow from the cold reservoir and the hotreservoir by allowing the cold liquid to overflow from the coldreservoir and into the hot reservoir or the hot liquid to overflow fromthe hot reservoir and into the cold reservoir; a chiller configured tocool the cold liquid; a first pump configured to pump the cold liquidfrom the cold reservoir to the chiller; a heater configured to heat thehot liquid; a second pump configured to pump the hot liquid from the hotreservoir to the heater; a user interface configured to allow a user toset one or more parameters of the rapid contrast therapy; and acontroller configured to operate the chiller, the heater, the firstpump, and the second pump based on the parameters selected by the userusing the user interface.

In some embodiments, the system further includes a first pressure sensorlocated on the bottom of the cold reservoir and a second pressure sensorlocated on the bottom of the hot reservoir.

In some embodiments, the system further includes a first liquid levelsensor in the cold reservoir and a second liquid level sensor in the hotreservoir.

In some embodiments, the system further includes an overflow conduitextending from an upper portion of the cold reservoir to an upperportion of the hot reservoir, wherein the overflow conduit providesfluid communication between the cold reservoir and the hot reservoir.

In some embodiments, the heater is disposed in the hot reservoir.

In some embodiments, the system further includes a heating elementdisposed in the cold reservoir.

In some embodiments, the system further includes a heater baffledisposed proximate the heater, wherein the heater baffle is configuredto induce convection of the hot liquid around the heater.

In some embodiments, the system further includes temperature sensorsconfigured to measure a temperature of the hot liquid and a temperatureof the cold liquid.

In some embodiments, the system further includes a third pump configuredto pump cold liquid from the cold reservoir to a therapy wrap, and afourth pump configured to pump hot liquid from the hot reservoir to thetherapy wrap.

In some embodiments, the system further includes a compressor configuredto pressurize and depressurize a therapy wrap.

In some embodiments, the controller is configured to level the liquidsin the hot reservoir and the cold reservoir when the system is not beingused to actively treat a patient.

In some embodiments, the controller is configured to level the liquidsin the hot reservoir and the cold reservoir when the first liquid levelsensor or the second liquid level sensor detects a critical liquidlevel.

In some embodiments, the system further includes a plurality of valvesconfigured to control the flow of liquids throughout the system.

In some embodiments, the valves are solenoid valves.

In some embodiments, a system for providing rapid contrast therapy isprovided. The system includes a cold reservoir configured to hold a coldliquid; a cold therapy supply valve in fluid communication with the coldreservoir, the cold therapy supply valve directing the flow of the coldliquid to a therapy device; a hot reservoir configured to hold a hotliquid; a hot therapy supply valve in fluid communication with the hotreservoir, the hot therapy supply valve directing the flow of the hotliquid to the therapy; and a return valve directing return flow from thetherapy device to at least one of the hot and cold reservoirs; and acontroller directing operation of the cold and hot therapy supply valvesto control the flow of the cold liquid and the hot liquid to the therapydevice, the controller directing operation of the return valve tocontrol the return liquid flowing from the therapy device to at leastone of the cold and hot reservoirs.

In some embodiments, the system further includes a first liquid levelsensor in the cold reservoir to measure a level of the cold liquid; asecond liquid level sensor in the hot reservoir to measure a level ofthe hot liquid; a first temperature sensor to measure a temperature ofthe cold liquid; a second temperature sensor to measure a temperature ofthe hot liquid; and a return temperature sensor for measuring atemperature of the return flow from the therapy device.

In some embodiments, the first temperature sensor is provided in coldliquid recirculation manifold and the second temperature sensor isprovided in the hot liquid recirculation manifold.

In some embodiments, the first temperature sensor is provided in thecold liquid reservoir and the second temperature sensor is provided inthe hot liquid reservoir.

In some embodiments, the controller directs return flow from the therapydevice to at least one of the cold and hot reservoirs after determiningthat the measured liquid level within each of the cold and hotreservoirs is within a target liquid level range, wherein the controllerdirects the return flow to either the cold reservoir or the hotreservoir depending on the temperature of the return flow such that thereturn flow is directed to the reservoir containing the liquid having aclosest temperature with the temperature of the return flow. The targetliquid level range in each of the cold and hot reservoirs is greaterthan a corresponding minimum liquid level and less than a correspondingmaximum liquid level.

In some embodiments, the controller directs return flow from the therapydevice to at least one of the cold and hot reservoirs after determiningthat the measured liquid level within each of the cold and hotreservoirs is within a target liquid level range, wherein the controllerdirects the return flow to the hot reservoir when the temperature of thereturn flow is greater than an average of the temperatures of cold andhot liquids.

In some embodiments, the controller directs return flow from the therapydevice to at least one of the cold and hot reservoirs after determiningthat the measured liquid level within each of the cold and hotreservoirs is within a target liquid level range, wherein the controllerdirects the return flow to the hot reservoir when the temperature of thereturn flow is greater than an average of the temperatures of cold andhot liquids by more than a predetermined offset amount.

In some embodiments, the predetermined offset amount is 0.5° F.

In some embodiments, the controller directs return flow from the therapydevice to at least one of the cold and hot reservoirs after determiningthat the measured liquid level within each of the cold and hotreservoirs is within a target liquid level range, wherein controllerdirects return flow to the hot reservoir when the temperature of thereturn flow is equal to or greater than the temperature of the hotliquid in the hot reservoir.

In some embodiments, the controller directs return flow from the therapydevice to at least one of the cold and hot reservoirs after determiningthat the measured liquid level within each of the cold and hotreservoirs is within a target liquid level range, wherein controllerdirects the return flow to the hot reservoir when the temperature of thereturn flow is greater than the temperature of the cold liquid in thecold reservoir.

In some embodiments, the controller directs return flow from the therapydevice to at least one of the cold and hot reservoirs after determiningthat the measured liquid level within each of the cold and hotreservoirs is within a target liquid level range, wherein the controllerdirects the return flow to the hot reservoir when the temperature of thereturn flow is greater than a maximum cold reservoir return temperature.

In some embodiments, the maximum cold reservoir return temperaturecorresponds to the temperature of the cold liquid in the cold reservoir(measured in ° F.) plus an offset amount,

In some embodiments, the wherein the offset amount is 0.5° F.

In some embodiments, the system further includes one or more conduitsextending between the cold reservoir and the hot reservoir, the conduitproviding fluid communication therebetween; and one or more cross-tankvalves for controlling flow through the conduit; wherein the controllerdirects operation of the one or more cross-tank valves to control flowbetween the cold and hot reservoirs, wherein the controller directsoperation of the one or more cross-tank valves in response to themeasured liquid level in each of the cold and hot reservoirs such thatthe liquid level in either the cold and hot reservoirs does not exceed amaximum liquid level or fall below a minimum liquid level.

In some embodiments, the one or more cross-tank valves of the conduit isbiased in a closed position.

In some embodiments, the system further includes a pump for movingliquid through the conduit.

In some embodiments, the conduit is connected to a recirculation pumpfor moving fluid through the conduit between the cold and hotreservoirs.

In some embodiments, the minimum liquid level of the cold and hotreservoirs is 60% of a full operating liquid level of the correspondingcold and hot reservoir.

In some embodiments, the minimum liquid level of the cold and hotreservoirs is 72% of a full operating liquid level of the correspondingcold and hot reservoirs.

In some embodiments, the minimum liquid level of the cold and hotreservoirs is 3.75″. In some embodiments, the full operating liquidlevel of the cold and hot reservoir ranges between 5-6″.

In some embodiments, the minimum liquid level is 3.6″. In someembodiments, the full operating liquid level of the cold and hotreservoir ranges between 5-6″.

In some embodiments, the controller directs flow through the conduitfrom the hot reservoir to the cold reservoir when the first liquid levelsensor measures a liquid level below the minimum liquid level for thecold reservoir, wherein the controller directs flow through the conduitfrom the cold reservoir to the hot reservoir when the second liquidlevel sensor measures a liquid level below the minimum liquid level forthe hot reservoir.

In some embodiments, the controller directs flow through the conduitfrom the cold reservoir to the hot reservoir when the first liquid levelsensor measures a liquid level above the maximum liquid level for thecold reservoir, wherein controller directs flow through the conduit fromthe hot reservoir to the cold reservoir when the second liquid levelsensor measures a liquid level above the maximum liquid level for thehot reservoir.

In some embodiments, during operation at least one of the cold and hotliquids is provided to a therapy device and the return flow is receivedfrom the therapy device and directed to the cold or hot reservoirs,wherein, during operation the controller directs operation of thecross-tank valve to open fluid communication between the reservoirs fora first time period.

In some embodiments, the controller directs cycled operation of thecross-tank valve to open and close fluid communication between thereservoirs, such that during each open-close cycle the cross-tank valveis open for the first time period and closed for a second time perioduntil the difference between the measured liquid levels in the cold andhot reservoirs is within a predetermined deviation amount.

In some embodiments, the first time period is 5 seconds and the secondtime period is 5 seconds.

In some embodiments, the minimum liquid level of the cold and hotreservoirs corresponds to a liquid level where the cold and hotreservoirs indicate a critically low operating condition.

In some embodiments, the predetermined deviation amount is ¼″±⅛″.

In some embodiments, the system is not operating when at least one ofthe cold and hot liquids have not been provided to the therapy devicefor a predetermined off period, wherein, when the system is notoperating, the controller directs operation of the cross-tank valve toopen fluid communication between the reservoirs for a first time period.

In some embodiments, the predetermined off period that the therapysystem is not operating is less than or equal to 20 seconds.

In some embodiments, the predetermined off period that the therapysystem is not operating is at least 5 second.

In some embodiments, the predetermined off period that the therapysystem is not operating is at least 10 seconds.

In some embodiments, the controller directs operation of the cross-tankvalve to open fluid communication between the reservoirs until thedifference between the measured liquid levels in the cold and hotreservoirs is within a predetermined deviation amount.

In some embodiments, the predetermined deviation amount is ¼″±⅛″.

In some embodiments, the controller directs cycled operation of thecross-tank valve to open and close fluid communication between thereservoirs, such that during each open-close cycle the cross-tank valveis open for the first time period and closed for a second time perioduntil the difference between the measured liquid levels in the cold andhot reservoirs is within a predetermined deviation amount.

In some embodiments, the first time period is 5 seconds and the secondtime period is 5 seconds.

In some embodiments, the predetermined deviation amount is ¼″±⅛″.

In some embodiments, the return valve comprises a cold reservoir returnvalve and a hot reservoir return valve, wherein the cold reservoirreturn valve directs return flow from the therapy device to the coldreservoir, wherein the hot reservoir return valve directs return flowfrom the therapy device to the hot reservoir.

In some embodiments, the system further includes at least one of thecold therapy supply valve, the hot therapy supply valve, the returnvalve and the cross-tank valve can be adjusted by the controller to varyat least one of a flow rate, volume, flow pressure, and temperature ofthe flow of liquid therethrough.

In some embodiments, the return temperature sensor is provided upstreamof the return valve such that the return temperature sensor is betweenan output of the therapy device and the return valve.

In some embodiments, the therapy device comprises a therapy wrapconfigured for wrapping to a portion of an animate body for deliveringtreatment.

In some embodiments, the cold reservoir includes a cold reservoir fillport and the hot reservoir includes a hot reservoir fill port, whereinthe cold and hot reservoir fill ports are housed in a receptacle that isconfigured to accommodate fluid overflow from the cold reservoir and thehot reservoir by allowing the cold liquid to overflow from the coldreservoir and into the hot reservoir or the hot liquid to overflow fromthe hot reservoir and into the cold reservoir.

In some embodiments, the system further includes a first pump configuredto pump cold liquid from the cold reservoir to the therapy device; and asecond pump configured to pump hot liquid from the hot reservoir to thetherapy device.

In some embodiments, the system further includes a chiller configured tocool the cold liquid, and a third pump (recirculating pump) configuredto pump the cold liquid from the cold reservoir to the chiller.

In some embodiments, the third pump (recirculating pump) is configuredto pump cold liquid to the hot reservoir.

In some embodiments, the third pump is located upstream of the firstpump.

In some embodiments, the cold therapy supply valve is located downstreamfrom the first pump

In some embodiments, the system further includes a heater configured toheat the hot liquid; and a fourth pump (recirculating pump) configuredto pump the hot liquid from the hot reservoir to the heater.

In some embodiments, the heater is disposed in the hot reservoir.

In some embodiments, the system further includes a heater baffledisposed proximate the heater, wherein the heater baffle is configuredto induce convection of the hot liquid around the heater.

In some embodiments, the fourth pump (recirculating pump) is configuredto pump hot liquid to the cold reservoir.

In some embodiments, the fourth pump is located upstream of the secondpump.

In some embodiments, the hot therapy supply valve is located downstreamfrom the second pump.

In some embodiments, the system further includes a first pressure sensorlocated on the bottom of the cold reservoir, and a second pressuresensor located on the bottom of the hot reservoir.

In some embodiments, the system further includes a heating elementdisposed in the cold reservoir.

In some embodiments, the system further includes an overflow conduitextending from an upper portion of the cold reservoir to an upperportion of the hot reservoir, wherein the overflow conduit providesfluid communication between the cold reservoir and the hot reservoir.

In some embodiments, the system further includes a compressor configuredto pressurize the therapy device.

In some embodiments, the system further includes a user interfaceconfigured to allow a user to set one or more parameters of the rapidcontrast therapy; and wherein the controller operates at least one of achiller, a heater, the first pump, and the second pump based on theparameters selected by the user using the user interface.

In some embodiments, a method for providing rapid contrast therapy usinga rapid contrast therapy device is provided. The method includesapplying a therapy wrap to a patient; connecting a therapy wrapconnector to a treatment device connector, the therapy device connectorproviding fluid communication between the therapy wrap and a coldtherapy supply line, a hot therapy supply line and a pressurized gassupply line; measuring a liquid level of a cold and hot liquid within acold and hot liquid reservoir provided in the therapy device; confirminga measured liquid level within each of the cold and hot reservoirs iswithin a target liquid level range; providing at least one of atemperature therapy and a pressure therapy to the patient via thetherapy wrap by directing at least one of a cold liquid, a hot liquidand a pressurized gas through therapy wrap via a corresponding coldtherapy supply valve, hot therapy supply valve and gas therapy supplyvalve; controlling via a return valve a return flow of the liquid fromthe therapy wrap to at least one of the cold and hot reservoirs tominimize the unnecessary thermal pollution of hot water from enteringthe cold tank or cold water from entering the hot tank upon return fromthe therapy wrap.

In some embodiments, the method the return flow is directed to eitherthe cold reservoir or the hot reservoir depending on the temperature ofthe return flow such that the return flow is directed to the reservoircontaining the liquid having a closest temperature with the temperatureof the return flow.

In some embodiments, the return flow is directed to the hot reservoirwhen the temperature of the return flow is greater than an average ofthe temperatures of cold and hot liquids.

In some embodiments, the return flow is directed to the hot reservoirwhen the temperature of the return flow is greater than an average ofthe temperatures of cold and hot liquids by more than a predeterminedoffset amount.

In some embodiments, the predetermined offset amount is 0.5° F.

In some embodiments, the return flow is directed to the hot reservoirwhen the temperature of the return flow is equal to or greater than thetemperature of the hot liquid in the hot reservoir.

In some embodiments, the return flow is directed to the hot reservoirwhen the temperature of the return flow is greater than the temperatureof the cold liquid in the cold reservoir.

In some embodiments, the return flow is directed to the hot reservoirwhen the temperature of the return flow is greater than a maximum coldreservoir return temperature.

In some embodiments, the maximum cold reservoir return temperaturecorresponds to the temperature of the cold liquid in the cold reservoir(measured in ° F.) plus an offset amount,

In some embodiments, the offset amount is 0.5° F.

In some embodiments, the measured liquid level within either of the coldand hot reservoirs is not within a target liquid level range the returnflow is directed to either the cold reservoir or the hot reservoirdepending on the measured liquid level in each of the cold and hotreservoirs such that the measured liquid level in the cold and hotreservoirs does not exceed the corresponding maximum liquid level orfall below the corresponding minimum liquid level.

In some embodiments, the return flow is directed to the cold reservoirwhen the first liquid level sensor measures a liquid level below theminimum liquid level for the cold reservoir, and wherein the return flowis directed to the hot reservoir when the second liquid level sensormeasures a liquid level below the minimum liquid level for the hotreservoir.

In some embodiments, the return flow is directed to the hot reservoirwhen the first liquid level sensor measures a liquid level above amaximum liquid level for the cold reservoir, and wherein return flow isdirected to the cold reservoir when the second liquid level sensormeasures a liquid level above the maximum liquid level for the hotreservoir.

In some embodiments, the method further includes directing a cross-tankflow of the cold and hot liquids between the cold and hot reservoirs viaa conduit operated by a cross-tank valve, where the cross-tank flow isdirected in response to the measured liquid levels in each of the coldand hot reservoirs such that the liquid level in either the cold and hotreservoirs does not exceed a maximum liquid level or fall below aminimum liquid level.

In some embodiments, the method further includes directing flow throughthe conduit from the hot reservoir to the cold reservoir when the firstliquid level sensor measures a liquid level below the minimum liquidlevel for the cold reservoir.

In some embodiments, the method further includes directing flow throughthe conduit from the cold reservoir to the hot reservoir when the secondliquid level sensor measures a liquid level below the minimum liquidlevel for the hot reservoir.

In some embodiments, the method further includes directing flow throughthe conduit from the cold reservoir to the hot reservoir when the firstliquid level sensor measures a liquid level above the maximum liquidlevel for the cold reservoir.

In some embodiments, the method further includes directing flow throughthe conduit from the hot reservoir to the cold reservoir when the secondliquid level sensor measures a liquid level above the maximum liquidlevel for the hot reservoir.

In some embodiments, the during operation of the therapy device at leastone of the cold and hot liquids is provided to the therapy wrap and thereturn flow is received from the therapy wrap and directed to the coldor hot reservoirs, wherein during operation of the therapy device,directing operation of the cross-tank valve to open fluid communicationbetween the reservoirs for a first time period.

In some embodiments, the method further includes directing cycledoperation of the cross-tank valve to open and close fluid communicationbetween the reservoirs, such that during each open-close cycle thecross-tank valve is open for the first time period and closed for asecond time period until the difference between the measured liquidlevels in the cold and hot reservoirs is within a predetermineddeviation amount.

In some embodiments, the minimum liquid level of the of the cold and hotreservoirs corresponds to a liquid level where the cold and hotreservoirs indicate a critically low operating condition.

In some embodiments, the therapy device is not operating when at leastone of the cold and hot liquids have not been provided to the therapywrap for a predetermined off period, when the therapy device is notoperating, directing operation of the cross-tank valve to open fluidcommunication between the reservoirs for a first time period.

In some embodiments, the method further includes directing cycledoperation of the cross-tank valve to open and close fluid communicationbetween the reservoirs, such that during each open-close cycle thecross-tank valve is open for the first time period and closed for asecond time period until the difference between the measured liquidlevels in the cold and hot reservoirs is within a predetermineddeviation amount.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the disclosure are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present disclosure will be obtained by reference tothe following detailed description that sets forth illustrativeembodiments, in which the principles of the disclosure are utilized, andthe accompanying drawings of which:

FIGS. 1A-1B illustrate a system for providing cold, heat/hot/warm(hereafter referred to as “hot”), and/or rapid contrast therapy.

FIG. 2 illustrates an embodiment of a user interface that can serve as acontrol panel.

FIG. 3 illustrates various pressure curve profiles.

FIGS. 4A and 4B illustrate an embodiment of a therapy wrap.

FIGS. 5A-5C illustrate an embodiment of the system being refilled usingthe refill port and drained using the drain ports.

FIGS. 6, 7, 8A and 8B are schematic diagrams that illustrate variousembodiments of the system.

FIGS. 9A and 9B illustrate an embodiment of a cold reservoir and a hotreservoir.

FIG. 10A-10B present various parameters that are used by the system.

FIGS. 11A-11O illustrate various screens displayed by the touch screeninterface.

FIG. 12 is graph of tank temperatures using various temperature controlalgorithms.

DETAILED DESCRIPTION

FIGS. 1A-1B and illustrate a system 1000 for providing cold,heat/hot/warm (hereafter referred to as “hot”), and/or rapid contrasttherapy, which involves rapidly alternating between cold therapy and hottherapy. The system can circulate cold or warm fluid, such as water,through a hose, into a therapy wrap, and then back to the fluidreservoirs of the system. The system can utilize a vapor compressionsystem or other chiller technology to cool the cold water reservoir, andimmersion heaters can be used to heat the hot water reservoir. Thesystem can have two or more ports, in order to serve two or morepatients simultaneously. Two or more air pumps can be utilized (one foreach port) in order to provide pneumatic compression along with thethermal therapy. In other embodiments, the system may have a single portand single air pump to treat just a single patient.

In some embodiments, the system 1000 can have a user interface 1002 onan upper front facing panel. The user interface 1002 can be a touchdisplay. An on/off power button 1004 can be provided. The on/off powerbutton can be located on, in or near the user interface 1002. The upperfront facing panel can also have a reservoir fill cover 1006 that can beopened to provide access to fill ports. Handles 1008 can also beprovided to allow the user to move the system, which can have a basewith 4 locking casters 1010. A removable or openable front cover 1012can provide access to the internal components of the system. Air vents1014, a hose holster 1016, and a connector hose 1018 can be located onone or both the sides of the system.

The rear of the system can have a fan 1020, additional air vents 1022,drain ports 1024, a USB port 1026 and/or network port, an additionalon/off power switch 1028, a power cord inlet 1030, and equipotentialground pins 1032.

Therapy Modalities:

COOLING: water can be supplied and returned to the cold reservoir ascontrolled by the flow control valves associated with the port. Sincethere is only one cold reservoir in some embodiments, the cold reservoirtemperature control may be common to both ports, or all ports forembodiments with more than 2 ports, and the temperature may beadjustable from the user interface, such as the home screen which can bethe default display screen. Each port can have individual settings fortreatment parameters, including treatment temperatures and duration andair pressure, which allow the system to deliver customized treatment toeach wrap connected to the system.

HEATING: water can be supplied and returned to the hot reservoir ascontrolled by the flow control valves associated with the port. Sincethere may be only one hot reservoir in some embodiments, the hotreservoir temperature control may be common to both ports, or all portsfor embodiments with more than 2 ports, and its temperature may beadjustable from the user interface, such as the home screen which can bethe default display screen. Each port can have individual settings fortreatment parameters, including treatment temperatures and duration andair pressure, which allow the system to deliver customized treatment toeach wrap connected to the system.

CONTRAST: water supplied to the wraps can alternate between the hot andcold reservoirs based on the separate and customizable hot duration andtemperature and cold duration and temperature settings. A typicaltreatment is alternating 3 min hot and 1 min cold. In some embodiments,durations of less than one min on either hot or cold therapy to preventthe wraps from being half filled with warm/hot water and half filledwith cold water. Air pressure can also be adjustable separately for thehot and cold treatments. For example the pressure could be set to high(i.e., 75 mmHg) during cold and med low (i.e., 25 mmHg) during hot. Insome embodiments, the pressure applied during cold treatment can behigher during cold treatment than hot treatment to work alongside withvasoconstriction during cold treatment. Heat causes vasodilation, andblood rushes in—so air pressure may be counterproductive with heattherapy, which means using a lower pressure during heat treatment may bebeneficial. In some embodiments, treatment duration selections may belimited to whole cycle values to end in a certain mode. For example, ahot and cold cycle may be limited to minute increments, and a combinedhot and cold cycle duration may be limited to a set value or upperlimit. For example, the single combined hot cold cycle may not exceed 4minutes in some embodiments, meaning if the hot treatment is 3 minutes,then the cold treatment is 1 minute. In some embodiments, a hot coldcycle may be limited to 2 to 10 minutes, or 4 to 20 minutes, or 2 to 30minutes. In some embodiments, the total treatment is configured to endwith cold treatment or hot treatment by configuring the treatment timesand number of cycles.

COMPRESSION ONLY: water is not pumped through the wraps but air oranother gas can be pumped into the wrap. Treatment duration, airpressure, and optionally the pressure curve profile (the ramping up,maintenance, and release of pressure over time) will be adjustable.

COMPRESSION WITH THERMAL THERAPY: The thermal therapies described hereincan be combined with the compression therapy.

Control Panel(S):

FIG. 2 illustrates an embodiment of a user interface 2000 that can serveas a control panel. The user interface 2000 can be a touch screen withgraphical icons that represent the different treatment modalities andcan include adjustable parameter settings, such as hot and coldtemperature settings for example. For example, the control panel can usea 7″ touchscreen TFT set in a traditional domed membrane switch. Most ofthe controls can be on the TFT display. A few buttons like power, STOP,home, etc. can be on the membrane switch. In some embodiments, acapacitive touch screen can be used.

Air Pressure Profiles:

In various embodiments, in the cooling mode the pressure of gasfurnished by the control unit is between about 0.25 psig and about 20psig, preferably between about 0.25 psig and about 5 psig, and morepreferably about 0.25 to about 1.5 psig. In various embodiments, thecontrol unit maintains a compressive force of between about 0.25 psigand about 5 psig. In various embodiments, the control unit maintains acompressive force of between about 0.25 psig and about 0.5 psig. Invarious embodiments, the pressure of gas furnished by the control unitis user selectable in increments of 5 mm Hg from 0 mm to about 75 mm.

In various embodiments, the pressure of gas furnished by the controlunit is based on the patient's response. For example, if the patient iswearing the wrap during exercise, the pressure may vary based on howstrenuous the exercise is. If the patient is having trouble breathing,the control unit may decrease the compressive force around the lungs.The pressure profile map may be set to adjust based on a predeterminedroutine. In various embodiments, the pressure profile map includes 3minutes of slowly increasing pressure followed by 2 minutes ofdecreasing pressure. In various embodiments, the pressure profile mapincludes 30 seconds of increasing pressure followed by 15 seconds ofdecreasing pressure. In various embodiments, the pressure fluctuates atrandom. In various embodiments, the pressure profile map includes 2minutes of compression followed by 1 minute with no compression.

The strength and frequency of the pulses may be modified depending onthe application. In various embodiments, the control unit deliverspulses of compression for massaging therapy.

In various embodiments the wrap can be used with a rigid or semi-rigidsupport such as a brace. In various embodiments, the control unit canapply and maintain a low pressure or no pressure when the control unitdetects a brace in use with the wrap. In various embodiments, thecontrol unit can apply and maintain higher pressures when the controlunit detects a brace not in use with the wrap. In some embodiments, alow pressure is less than 10 psig, 5 psig, 4 psig, 3 psig, 2 psig, 1psig, or 0.5 psig. In some embodiments, a high pressure is greater than0.5 psig, 1 psig, 2 psig, 3 psig, 4 psig, 5 psig, or 10 psig.

In heating mode, the same pressures will be available as for the coldsettings.

FIG. 3 illustrates various pressure curve profiles: high (about 75mmHg), medium high (about 50 mmHg), medium low (about 25 mmHg), and low(about 15 mmHg). The ramp time can be about 2 minutes to achieve thetarget pressure for high, medium high, and medium low, while the ramptime for low can be about 1 minute. The ramp times and targettemperatures for the different settings can be adjustable, or can bepredetermined and fixed.

In some embodiments, the default pressures for the cooling and heatingmodes is different. In other embodiments, the default pressures for thecooling and heating modes is the same.

In contrast therapy mode, the therapy profile can specify the coldduration and temperature and compression, the hot duration andtemperature and compression, and the duration of treatment or number ofcycles to be run.

In some embodiments, the system allows named preset therapy sessions tobe configured and saved by the user that can be later selected directlyby name and/or a unique icon.

Wraps:

Further details regarding wraps, fluid bladders, air bladders, and theiroperation and manufacture are described in U.S. Pat. Nos. 7,837,638;7,198,093 and 6,695,872, both to Elkins, U.S. Patent Publication Nos.2014/0142473, the entire contents of which are incorporated herein forall purposes by reference.

FIGS. 4A and 4B illustrate an embodiment of a therapy wrap. The therapywrap 20 is configured for wrapping to a portion of an animate body fordelivering treatment. The body may include, but is not limited to, amammalian body such as a human or an equine animal. The exemplarytherapy wrap is in the form of a sleeve for connecting variouscomponents of heat transfer device 22 to the patient's body. The sleeveis similar in many respects to the sleeve disclosed by U.S. Pat. No.7,896,910 to Schirrmacher et al. and cover disclosed by U.S. Pat. No.6,695,872 to Elkins, the entire contents of which patents areincorporated herein for all purposes by reference.

Exemplary therapy wrap 20 includes an opening 19 for directing heattransfer device 22 into a pouch or cavity in the sleeve interior. Aportion of sleeve may be pulled back to reveal the pouch and facilitatepositioning of the heat transfer device in the pouch as shown in FIG.4A. Any suitable fastening means can be used to close the opening suchas, but not limited to, a zipper.

The pouches may be selectively positioned in predetermined locations ontherapy wrap 20. In other words, the pouches may be fixed into aposition on the wrap based on parameters defined before use of the wrap.Such parameters may include user preferences or application demands. Invarious embodiments, the sleeve is configured to position a bladder inone of a plurality of predefined locations. The predefined locations maybe determined by user preferences. In various embodiments, thepredefined locations correspond to key areas for core cooling of thebody.

Therapy wrap 20 may have a variety of shapes and sizes for applying todifferent portions of the body or different body anatomies. The sleevemay be shaped and configured for application to a mammal, and in variousembodiments, a human. In various embodiments, the sleeve is shaped forapplying to and covering all or part of a torso, a thoracic region, acranial region, a throat region, a limb, and a combination of the same.Various aspects of the therapy wrap, in particular the sleeve, shape anddesign may be similar to the devices disclosed by U.S. Pat. No.7,107,629 to Miros et al. and U.S. Patent Pub. No. 2005/0256556 A1 toSchirrmacher et al., the entire contents of which are incorporatedherein for all purposes by reference.

In general, “heat transfer device” refers to the body heat exchangingcomponent(s). In various embodiments, the heat transfer device includeslayers of material defining a flexible fluid bladder through which aliquid is circulated and a gas bladder in which a pressurized gas isinjected. Exemplary heat transfer device 22 is in the form of aconventional multi-bladder assembly for positioning adjacent a treatmentsite of a body. In various aspects, the multi-bladder assembly ismanufactured and configured using known techniques. A commonly usedthermal bladder assembly uses both a compliant fluid bladder 25 forcirculating heat transfer fluid and a gas pressure bladder 28 whichoverlays the fluid bladder (best seen in FIG. 4B). The gas pressurebladder is adapted to inhibit edema and/or for pressing the fluidbladder against the body part to be subjected to heat exchange.

More specifically, outer gas pressure bladder 28 is adapted to receive afirst fluid such as a gas (e.g., air) that can be regulated to providethe desired amount of inflation of the bladder or pressure therein. Thisinflation or pressure affects the compressive force applied to theanimate body during use. Inner fluid bladder 25 is adapted to receive afluid, such as a coolant which can be in the form of a cold liquid, totransfer heat away from the animate body part. Alternatively, the fluidsupplied to the inner bladder can have a temperature higher than theanimate body part to heat the body part.

The hose and connector to attach the therapy wrap to the system can usea 3-port connector with a fluid inlet, a fluid outlet, and a gas port.

Approximate Dimensions for One Embodiment of the System

Height 40 inches 1016 mm Length 20 inches 500 mm Width 17 inches 430 mmWater Volume 3 gallon (1-5 gallons) 11 liter Weight 150 pounds 45 Kg

Water Temperatures:

In some embodiments, the temperature of the hot reservoir can beadjustable from about 100 to 120 degF, and the temperature of the coldreservoir can be adjustable from about 38 to 60 degF. The temperatureranges can be determined by safety considerations (i.e., avoiding tissuedamage) and freeze prevention of fluid in cold reservoir. In someembodiments, the range limits can be adjusted by the user. For examplethe upper range for the hot reservoir can be lowered by the user to, forexample, 110 or 115 F, and/or the lower range for the cold reservoir canbe increased to 40 or 45 or 50 F. In some embodiments, the useradjustable range is limited to adjustments made within a predeterminedrange so that the user cannot exceed a predetermined hot temperaturelimit or fall below a predetermined cold temperature limit.

Water:

In some embodiments, distilled water is provided and/or recommended foruse to reduce scaling. In the event distilled water is not used,descaling agents such as phosphoric acid, acetic acid, or citric acidcan be flushed through the system. Instructions for descaling the systemcan be provided.

In some embodiments, addition of an antimicrobial and or scale inhibitermay also be recommended.

In some embodiments, the system is drained when not in use anddrained/refilled periodically. As shown in FIGS. 5A-5C, to facilitatedraining and refilling, the system 5000 can have easily accessible drainports 5002 and fill ports 5004. The fill ports 5004 can be located onthe front facing portion of system near the user interface for increasedaccess, which allows the user to easily add more fluid to the system ifneeded, even during treatment. A removable or openable cover 5006 cancover the fill ports 5004.

Temperature Control:

To make a reasonably sized system, the ratio of thermal mass to heattransfer suggests deviating from the traditional refrigerationtemperature control methods.

FIGS. 6-8B are schematic diagrams that illustrate various embodiments ofthe system. As shown in FIG. 6 , in some embodiments with an AC system,a hot gas bypass 6000 can be used and temperature can be controlled withan isolation valve 6002 upstream of the thermal expansion valve 6004. Asshown in FIG. 7 , if a variable speed DC compressor 7000 is used thepower may be lowered to allow use of a heater 7002 in the cold tank7004. FIG. 8A illustrates a schematic of the cold tank portion, and FIG.8B illustrates a schematic of the hot tank portion. FIGS. 8A and 8Billustrate pumps 8001, 8002, 8003, 8004 that can be used to pump fluidtoo the chiller 8005, the heater 8006, and between the cold tank 7004and the hot tank 8007. For example, recirculation pump 8001 can be usedto direct flow from the cold tank 7004 to the hot tank 8007, andrecirculation pump 8003 can be used to direct flow from the hot tank8007 to the cold tank 7004. The pumps in combination with a system ofvalves can be used to control the fluid flow in the system.

Return Water Strategy (i.e. when in Rapid Contrast Mode).

In order to make the cooling and heating systems more efficient, it willbe advantageous to delay switching of return water for a period of timeafter switching from hot to cold or from cold to hot, i.e., whenswitching from hot to cold, there will be about 300-750 ml or some othervolume of hot water still in the hoses and wraps. If return waterswitched at the same time as the supply water, a large volume of hotwater would be pumped into the cold water tank. The inverse would betrue when switching from cold back to hot. Return water switching couldbe delayed until the return water reached a predetermined temperature ortime, which can be measured using a temperature sensor, such as athermistor. Switching between reservoirs can be achieved using solenoidvalves that can be opened and closed based on measurements from thetemperature sensor. For example:

T=(Th−Tc)/2

T=Th−10 F (when switching from cold to hot)

T=Tc+10 F (when switching from hot to cold)

Time=60 seconds

Tank System

When water supply is switched during contrast therapy, the tanks willoften be at different levels. There should be a method of protecting thesystem from overflow of one tank or another, and also a system toprevent one tank from running low on fluid.

A small equalization tube 6500 may be a solution as shown in FIGS. 6 and7 . This equalization tube 6500 would allow the tanks to equalize. Thelength and diameter of the tube could be sized to prevent fastequalization (which would dump hot water into the cold tank or viceversa). For example, the length and diameter of the tube can be sized toallow up to about 1%, 5%, or 10% of the tank volume in fluid to passthrough per minute. The equalization tube 6500 can be located on theupper portion of each tank, such as the upper 1/20, 1/10, ⅕, ¼, or ⅓.

A reversible pump between the reservoirs is another possible solution.This would have the advantage of being able to stop or startequalization at any time, and in any direction. Further advantage wouldbe that hot water could be added to the cold tank, or vice versa, inorder to more rapidly reach a desired tank temperature (i.e., whenchanging tank temperatures) or to prevent overshoot, etc.

Another solution can be for overflow to be passed back and forth betweenthe tanks at the filling ports shown in FIG. 5C. The filling ports canbe housed in a receptacle that can accommodate fluid overflow from thereservoirs. As one reservoir overflows through its filling port, thereceptacle is filled and the overflow fluid flows into the filling portof the other reservoir.

If the liquid levels in the tanks are equilibrated or balanced duringtherapy, either hot water is added to the cold tank or cold water isadded to the hot tank, which reduces the temperature gradient betweenthe hot and cold tanks. This change in tank temperatures during therapymay not be desirable. Therefore, in some embodiments, tank fluid levelmanagement, particularly the liquid leveling steps as described herein,can be generally performed outside of therapy, such as after therapy iscompleted. However, when the liquid level in a tank is critically low, aliquid leveling procedure can be used even during therapy to return thetank levels to non-critical levels. This liquid leveling procedure canbe implemented, for example, through control of the pumps describedherein in connection with FIGS. 8A and 8B, for example.

It would be advantageous to make filling the system easy and intuitive.Since there will be two tanks, it may be advantageous to only have onefill port, and not have to fill each reservoir individually. In otherembodiments, each reservoir can have its own fill port, as shown in FIG.5B. Directing the water into both the hot tank and cold tank equally maybe a challenge. If the fill line is above the level of each reservoir,then both reservoirs would equalize at that point. However, that doesnot leave room for additional head height in either tank during use, andthe two tanks would mix freely, thus making temperature control of eachtank more difficult and inefficient. In some embodiments, an indicatoron the user interface can indicate the fill level of the reservoirsand/or can indicate when a reservoir is fully filled. The tanks can havea fluid level sensor to determine the amount of fluid in the tank.

Therefore, an embodiment of a reservoir that addresses these concerns isshown in FIGS. 9A and 9B. The system comprises a Cold Reservoir 9001, aHot Reservoir 9002 and a Fill Port 9006. Water may be poured into theFill Port 9007 using a pitcher, hose, gallon jug, etc. Ease of fillingmay be aided by use of a wide, funnel or tapered shape to the fill port9007. The fill port 9007 may be sealed by a Fill Cap assembly 9004. Thefill cap assembly 9004 may include a Knob 9004A a strainer 9004B and aTank Seal 9004C. The Tank Seal 9004C may be configured to provide anopening between the reservoirs and the ambient environment in oneposition (open position), and to seal the opening between the reservoirsand the ambient environment in another position (closed position). Inthe open position, there may be a conduit that connects the Hot and ColdReservoirs. This allows for water to equalize between the hot and coldreservoirs once an adequate fill level is attained (between the UpperFill Level 9020 and Lower Fill Level 9021. When the Tank Seal 9004C isin the Closed Position, the conduit between the Hot and Cold reservoirsmay be closed off, in order to prevent exchange of fluid as fluid levels9008A-B and 9009A-B change independently within the system. Vents 9005,9006 in the Reservoirs 9002, 9001 allow for the air pressure within thetanks to be nearly atmospheric.

Cold Water Outlet 9010 and Hot Water Outlet 9011 may be located at thebottom surface of the reservoir, or may be at a level just above thereservoir bottom to prevent sediment from entering the fluidics lines.Cold Water Inlet 9012 and Hot Water Inlet 9013 would desirably beconfigured such to encourage mixing within the reservoir. Proper mixing,or forced convection around the Heater 9015, is particularly importantto efficiently heat the water tank, and reduce surface temperature onthe heater, which in turn reduces the likelihood of scaling developingon the Heater 9015. For this reason, it may be desirable to include aHeater Baffle 9014 near the heater increase water velocity around theheater surface. The Heater Baffle 9014 may be designed such to provide atorturous water path to further reduce the boundary layer at the surfaceof the heater. A similar approach may be used if a Heater is used in theCold Reservoir as well.

A sensor (preferably a Pressure Sensor) may be used in order to sensethe water level in the tank. The Pressure Sensor 9016, 9018 would bebest placed near the bottom of the tank to most accurately measure HeadPressure within the tank. Reservoir Vents 9005, 9006 would allow foraccurate pressure measurement.

Water level may be equalized or adjusted via a Tank Level Facilitator9003 located adjacent to the reservoirs. The Tank Level Facilitator 9003may be passive, and could comprise of a simple orifice, or long lengthof tubing sized to provide a desired flowrate between the two reservoirsbase simply on water level difference. The Tank Level Facilitator 9003may also be an active device that pumps fluid from the Hot Reservoir9002 to the Cold Reservoir 9001 or vice versa. This may be desirable ifa significant water level imbalance is sensed, or to adjust thetemperature in one of the tanks rapidly. In addition to or in lieu ofthe tank head Pressure Sensors 9016, 9018, alternative liquid levelsensors or switches may be employed in order to provide a means ofidentifying whether the tank is above or below a certain point. This maybe valuable as a redundant indicator, or to ensure that water was alwaysabove the heater element.

An overflow prevention means may be to add an Overflow Conduit 9022between the two Reservoirs. This may provide for a more rapid exchangeof excess water to the opposite tank than could be done with a passiveversion of the Tank Level Facilitator 9003.

Furthermore, Overflow Drains 9023, 9024 may be utilized in order toroute excess water to outside the device, (in an overflow tank, or ontothe ground). Additional sensors could be added to the Overflow Drains9023, 9024 to sense this condition, or a means to detect moisture in theoverflow tank could be added.

Parameters for using the system are shown in FIG. 10A-10B.

Various screens displayed by the touch screen interface are shown inFIGS. 11A-11O. The system can include a controller and/or processor andmemory for storing instructions and programming to implement the userinterfaces described herein as well as controlling the system asdescribed herein. The various components, such as the pumps, thesensors, the compressors, the heat exchangers, the heaters, and thevalves, can be controlled by the processor and/or send information tothe processor.

Thermal Performance Optimization in a Thermal Therapy Device

Hot and Cold Tank reservoir temperatures may deviate if tank levelduring therapy, as water fills the heat exchangers and then returns toeither the hot tank or cold tank. Particularly during contrast therapy,water is returning to either the hot tank or cold tank. In the currentembodiment, water is returned to the tank in which the temperature isclosest to avoid unnecessary thermal pollution of excessively hot waterentering the cold tank, or excessively cold water from entering the hottank.

Over extended therapy times, or with larger heat exchanger volumes, thismay lead to a condition where one of the tanks fills up and the otherone gets too empty. This problem may be solved by keeping the tanksequalized during therapy by, for instance, pumping water from the highertank to the lower tank. Or, connecting the tanks with a small diametertube to allow tanks to equalize over time. This has the disadvantage ofbrining the emptier tank away from its set temperature, due to the othertank water entering the tank. For instance, if hot water is pumped intothe cold tank to increase the tank level, the hot water will increasethe temperature in the cold tank. It is not desirable to have therapytemperatures vary excessively away from the set point in this manner.

Increasing the tank size helps eliminate this condition because if thetank is sufficiently large, there is no worry of getting too full or tooempty. However, the larger the tank volume, the longer it takes forreservoir temperatures to reach set point. So excessively large tanksmay provide more stable temperature over time and provide plenty of roomfor large heat exchangers to be used without the tanks getting too fullor too empty, but it may take an unacceptable amount of time for thesystem to reach desired set point. For instance, with 8 liter tanks,when turning the system on in the morning with the reservoir water atroom temperature, it may take 30 minutes to reach set point. When with 4liter tanks, it may only take 15 minutes to reach set point which ismore desirable for the customer.

To keep the tanks closest to set point, an algorithm has been developedto optimize water temperature during therapy while keeping tank volumessmall enough to allow for acceptable cool down and heat up times.

During therapy, the tanks will not be equalized in order to preventunnecessary cross tank thermal pollution. However, if the water levelsget too low or too full (overflow), preventative steps may be taken: forinstance, at a predetermined level, the water returning from the heatexchanger(s) may be diverted to the lower tank instead of the tank ofthe closest temperature. This is more beneficial than sending water fromthe opposite tank, as the return water will be closer to the lower tanktemperature than the opposite tank. As a further preventative measure,if the tank level gets critically low, cross tank flow may be initiated.

Similarly, if one tank gets too full, it will begin overflowing into theother tank. This causes thermal pollution in a similar manner as crosstank flow.

For instance, the water return valves may perform in the followingmanner:

-   -   If both tank levels exceed 3.75″ H2O AND return temperature is        greater than average of hot tank recirculating temp and cold        tank recirculating temp by more than 0.5° F. then the Hot Tank        Return Valve shall be open, otherwise it is closed.    -   Open Hot Tank Return valve if the hot tank level is ≤3.75″ H2O    -   If hot tank level exceeds 10″ H2O, close hot tank valve until        hot tank level drops below 7″ H2O.    -   If the Hot tank return valve is closed, then the Cold Tank        Return valve shall be open—otherwise it is closed.

And the tank to tank valves may perform in the following manner:

-   -   Cold tank to hot tank valve:        -   By default the valve between the cold tank to hot tank shall            be closed.        -   The valve between the cold tank to hot tank shall perform            differently depending on whether Thermal Therapy is active:            -   When Thermal Therapy is not active or has not been                active for 10 seconds, The valve between the cold tank                to hot tank shall be open for 5 seconds and then closed                for 5 seconds if the cold tank water level is an                absolute delta of ¼″ (±⅛″) greater than the hot tank                water level in order to maintain equal tank levels in                between therapies.            -   When Thermal Therapy is active, the valve between the                cold tank to hot tank shall be open for 5 seconds and                then closed for 5 seconds if the hot tank level is less                than 3.6″ H2O AND cold tank level exceeds 3.6″ H2O.    -   Hot tank to Cold tank valve        -   By default the valve between the hot tank to the cold tank            shall be closed.        -   The valve between the hot tank to cold tank shall perform            differently depending on whether Thermal Therapy is active:            -   When Thermal Therapy is not active or has not been                active for 10 seconds, The valve between the hot tank to                cold tank shall be open for 5 seconds and then closed                for 5 seconds if the cold tank water level is an                absolute delta of ¼″ (±⅛″) greater than the hot tank                water level in order to maintain equal tank levels in                between therapies.            -   When Thermal Therapy is active, the valve between the                hot tank to cold tank shall be open for 5 seconds and                then closed for 5 seconds if the hot tank level is less                than 3.6″ H2O AND cold tank level exceeds 3.6″ H2O.

Once therapies end, there will be a tank equalization period where tankswill equalize, at which point the tank with the lower level will getwater added from the tank of the higher level. This will thermallypollute one of the tanks, and some time would be required for the tankto get back to set point.

Adding a delay mechanism between the end of therapy and the tankequalization period may be desired in case the user wants to use thesystem right away while the tanks are near their set temperature. Thedelay could be a fixed period of time (i.e. 10 seconds), or could takethe form of a “do not equalize” button.

A graph of the thermal performance is shown in FIG. 12 and is presentedas an example of tank temperatures before and after the enhancedalgorithm. The therapy in the example below is a Rapid Contrast Therapywith a straight knee wrap on each port (port 1 and port 2) with 3minutes on cold, followed by 3 minutes on hot therapy, alternating backand forth for a total of 30 minutes. Two versions of software(containing the algorithms) are presented. V1.1.6 is the improvedalgorithm that does not equalize the tanks during therapy. V1.1.5 keepstanks equalized during therapy to within a certain limit.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the disclosure.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present disclosure.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions.

For example, a numeric value may have a value that is +/−0.1% of thestated value (or range of values), +/−1% of the stated value (or rangeof values), +/−2% of the stated value (or range of values), +/−5% of thestated value (or range of values), +/−10% of the stated value (or rangeof values), etc. Any numerical values given herein should also beunderstood to include about or approximately that value, unless thecontext indicates otherwise. For example, if the value “10” isdisclosed, then “about 10” is also disclosed. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.It is also understood that when a value is disclosed that “less than orequal to” the value, “greater than or equal to the value” and possibleranges between values are also disclosed, as appropriately understood bythe skilled artisan. For example, if the value “X” is disclosed the“less than or equal to X” as well as “greater than or equal to X” (e.g.,where X is a numerical value) is also disclosed. It is also understoodthat the throughout the application, data is provided in a number ofdifferent formats, and that this data, represents endpoints and startingpoints, and ranges for any combination of the data points. For example,if a particular data point “10” and a particular data point “15” aredisclosed, it is understood that greater than, greater than or equal to,less than, less than or equal to, and equal to 10 and 15 are considereddisclosed as well as between 10 and 15. It is also understood that eachunit between two particular units are also disclosed. For example, if 10and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the disclosure as described by the claims. Forexample, the order in which various described method steps are performedmay often be changed in alternative embodiments, and in otheralternative embodiments one or more method steps may be skippedaltogether. Optional features of various device and system embodimentsmay be included in some embodiments and not in others. Therefore, theforegoing description is provided primarily for exemplary purposes andshould not be interpreted to limit the scope of the disclosure as it isset forth in the claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“disclosure” merely for convenience and without intending to voluntarilylimit the scope of this application to any single disclosure orinventive concept, if more than one is, in fact, disclosed. Thus,although specific embodiments have been illustrated and describedherein, any arrangement calculated to achieve the same purpose may besubstituted for the specific embodiments shown. This disclosure isintended to cover any and all adaptations or variations of variousembodiments. Combinations of the above embodiments, and otherembodiments not specifically described herein, will be apparent to thoseof skill in the art upon reviewing the above description.

1.-19. (canceled)
 20. A system for providing rapid contrast therapy, thesystem comprising: a cold reservoir configured to hold a cold liquid,the cold reservoir including a first liquid level sensor to measure alevel of the cold liquid and a first temperature sensor to measure atemperature of the cold liquid; a hot reservoir configured to hold a hotliquid, the hot reservoir including a second liquid level sensor tomeasure a level of the hot liquid and a second temperature sensor tomeasure a temperature of the hot liquid; a return valve for directingreturn flow from a therapy device to the hot reservoir and the coldreservoir; a return temperature sensor for measuring a temperature ofthe return flow from the therapy device; and a controller directingoperation of the return valve to control the return flow from thetherapy device to the cold and hot reservoirs, wherein: if the level ofthe cold liquid and the hot liquid are within a target liquid levelrange, the controller directs the return flow to one of the coldreservoir or the hot reservoir having a closest temperature with thetemperature of the return flow, and if the level of either the coldliquid or the hot liquid falls below a lower limit of the target liquidlevel range, the controller directs the return flow to a correspondingone of the cold reservoir or the hot reservoir.
 21. The system of claim20, wherein if the level of either the cold liquid or the hot liquidexceeds an upper limit of the target liquid level range, the controllerdirects the return flow to an opposite one of the cold reservoir or thehot reservoir.
 22. The system of claim 20, further comprising: a coldtherapy supply valve in fluid communication with the cold reservoir, thecold therapy supply valve directing a flow of the cold liquid to atherapy device; and a hot therapy supply valve in fluid communicationwith the hot reservoir, the hot therapy supply valve directing a flow ofthe hot liquid to the therapy device, wherein the controller directsoperation of the cold therapy supply valve and the hot therapy supplyvalve.
 23. The system of claim 20, further comprising: a conduitextending between the cold reservoir and the hot reservoir, the conduitproviding fluid communication therebetween; and one or more cross-tankvalves for controlling flow through the conduit, wherein: the controllerdirects operation of the one or more cross-tank valves to control flowbetween the cold and hot reservoirs, and the controller directsoperation of the one or more cross-tank valves in response to a measuredliquid level in each of the cold and hot reservoirs such that the levelof the cold liquid in the cold reservoir and the level of the holdliquid in the hot reservoir do not exceed an upper limit or fall belowthe lower limit of the target liquid level range.
 24. The system ofclaim 23, wherein the controller directs flow through the conduit: fromthe hot reservoir to the cold reservoir when the first liquid levelsensor measures a liquid level below the lower limit of the targetliquid level range, from the cold reservoir to the hot reservoir whenthe second liquid level sensor measures a liquid level below the lowerlimit of the target liquid level range, from the cold reservoir to thehot reservoir when the first liquid level sensor measures a liquid levelabove the upper limit of the target liquid level range, or from the hotreservoir to the cold reservoir when the second liquid level sensormeasures a liquid level above upper limit of the target liquid levelrange.
 25. The system of claim 23, wherein the system is not operatingwhen at least one of the cold and hot liquids have not been provided tothe therapy device for a predetermined off period and, when the systemis not operating, the controller directs operation of one or more of thecross-tank valves to open fluid communication between the cold and hotreservoirs for a first time period.
 26. The system of claim 25, whereinthe predetermined off period that the system is not operating is between5 and 20 seconds.
 27. The system of claim 25, wherein the controllerdirects operation of one or more of the cross-tank valves to open fluidcommunication between the reservoirs until a difference between themeasured liquid levels in the cold and hot reservoirs is within apredetermined deviation amount.
 28. The system of claim 25, wherein thecontroller directs cycled operation of one or more of the cross-tankvalves to open and close fluid communication between the reservoirs,such that during each open-close cycle the one or more of cross-tankvalves is open for the first time period and closed for a second timeperiod until a difference between the measured liquid levels in the coldand hot reservoirs is within a predetermined deviation amount.
 29. Amethod of operating a rapid contrast therapy device, the methodcomprising: measuring liquid levels of both a cold liquid within a coldliquid reservoir and a hot liquid within a hot liquid reservoir of therapid contrast therapy device; determining whether the measured liquidlevels are within a target liquid level range; and controlling, via areturn valve, a return flow of liquid from a therapy wrap of the rapidcontrast therapy device to at least one of the cold liquid reservoir orthe hot liquid reservoir to minimize thermal pollution of hot water fromentering the cold liquid reservoir or cold water from entering the hotliquid reservoir upon return from the therapy wrap, wherein: if thelevel of the cold liquid and the hot liquid are within a target liquidlevel range, the return flow is directed to one of the cold liquidreservoir or the hot liquid reservoir having a closest temperature witha temperature of the return flow, and if the level of either the coldliquid or the hot liquid falls below a lower limit of the target liquidlevel range, the return flow is directed to a corresponding one of thecold liquid reservoir or the hot liquid reservoir.
 30. The method ofclaim 29, wherein if the level of either the cold liquid or the hotliquid exceeds an upper limit of the target liquid level range, thereturn flow is directed to an opposite one of the cold liquid reservoiror the hot liquid reservoir.
 31. The method of claim 29, wherein therapid contrast therapy device includes a conduit extend between the coldliquid reservoir and the hot liquid reservoir and a cross-tank valve forcontrolling flow through the conduit, the method further comprising:operating the cross-tank valve to allow fluid to flow between the coldand hot liquid reservoirs such that the liquid level in either the coldand hot liquid reservoirs does not exceed an upper limit or fall belowthe lower limit of the target liquid level range.
 32. The method ofclaim 31, the method further comprising operating the cross-tank valveto direct flow through the conduit: from the hot liquid reservoir to thecold liquid reservoir when the level of the cold liquid falls below thelower limit of the target liquid level range, from the cold liquidreservoir to the hot liquid reservoir when the level of the hot liquidfalls below the lower limit of the target liquid level range, from thecold liquid reservoir to the hot liquid reservoir when the level of thecold liquid exceeds the upper limit of the target liquid level range, orfrom the hot liquid reservoir to the cold liquid reservoir when thelevel of the hot liquid exceeds the upper limit of the target liquidlevel range.
 33. The method of claim 31, wherein the rapid contrasttherapy device is not operating when at least one of the cold and hotliquids have not been provided to the therapy wrap for a predeterminedoff period, wherein, when the rapid contrast therapy device is notoperating, the method further includes opening the cross-tank valve fora first time period.
 34. The method of claim 33, wherein thepredetermined off period that the rapid contrast therapy device is notoperating is between 5 and 20 seconds.
 35. The method of claim 33,wherein the cross-tank valve is held open until a difference between themeasured liquid levels in the cold and hot liquid reservoirs is within apredetermined deviation amount.
 36. The method of claim 33, furthercomprising: cyclically operating the cross-tank valve to open and closefluid communication between the cold and hot liquid reservoirs, suchthat during each open-close cycle the cross-tank valve is open for thefirst time period and closed for a second time period until a differencebetween the measured liquid levels in the cold and hot liquid reservoirsis within a predetermined deviation amount.
 37. A controller for a rapidcontrast therapy device, the controller comprising: a processor; andmemory having instructions stored thereon that, when executed by theprocessor, cause the controller to: measure liquid levels of both a coldliquid within a cold liquid reservoir and a hot liquid within a hotliquid reservoir of the rapid contrast therapy device via respectivetemperature sensors; determine whether the measured liquid levels arewithin a target liquid level range; and control a return valve of therapid contrast therapy device to direct a return flow of liquid from atherapy wrap of the rapid contrast therapy device to at least one of thecold liquid reservoir or the hot liquid reservoir, wherein if the levelof the cold liquid and the hot liquid are within a target liquid levelrange, the return flow is directed to one of the cold liquid reservoiror the hot liquid reservoir having a closest temperature with thetemperature of the return flow, and wherein if the level of either thecold liquid or the hot liquid falls below a lower limit of the targetliquid level range, the return flow is directed to a corresponding oneof the cold liquid reservoir or the hot liquid reservoir.
 38. Thecontroller of claim 37, wherein if the level of either the cold liquidor the hot liquid exceeds an upper limit of the target liquid levelrange, the return flow is directed to an opposite one of the cold liquidreservoir or the hot liquid reservoir.
 39. The controller of claim 37,wherein the instructions further cause the controller to: control across-tank valve on a conduit extending between the cold liquidreservoir and the hot liquid reservoir of the rapid contrast therapydevice to direct flow through the conduit such that the liquid level ineither the cold and hot liquid reservoirs does not exceed an upper limitor fall below the lower limit of the target liquid level range.